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Recruiting

Population:
PAH
Start Date:
November 2017
End Date:
July 2022
Phase:
III
Institution:
Actelion
Study Summary
  • This is a prospective, multicenter, open-label, randomized, controlled, parallel group, group-sequential, event-driven Phase 3 study to evaluate efficacy, safety and pharmacokinetics (PK) of macitentan in children.
Population:
PAH
Start Date:
April 2016
End Date:
December 2019
Phase:
IV
Institution:
University of Calgary & Bayer
Study Summary
  • This is a prospective, multi-center, open-label, exploratory study with patients followed for a period of one year. The treatment duration period in this study begins at the initiation of ambrisentan plus riociguat and will continue for 12 months. Patients will come to clinic for a visit at month 4 and 12. Assessments will include Right Heart Catheterization, 6 Minute walk test, cardiac MRI, questionnaires and nt-Pro-BNP.

     
Population:
PAH
Start Date:
October 2018
End Date:
December 2019
Phase:
Early Phase I
Institution:
Laval University
Study Summary
  • The primary objective of the study is to confirm feasibility, to support the safety of using olaparib in PAH patients, and precise the sample size of the coming Phase 1B trial. The feasibility of the comprehensive patient phenotyping that will be proposed within the phase 1B trial will thus be assessed, in addition to adverse events and efficacy signals. We hope to extend our preclinical findings on the role of DNA damage and poly(ADP-ribose) polymerases (PARP) inhibition as a therapy for a devastating disease, pulmonary arterial hypertension (PAH), to early-phase clinical trials. We, and others, have published strong evidence that DNA damage accounts for disease progression in PAH and showed that PARP1 inhibition can reverse PAH in several animal models.
Population:
PAH
Start Date:
November 2011
End Date:
February 2020
Phase:

Institution:
Duke University
Study Summary
  • Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
Population:
PPH
Start Date:
August 5, 2013
End Date:
December 31, 2018
Phase:
III
Institution:
Pfizer
Study Summary
  • Neonates With Persistent Pulmonary Hypertension Of The Newborn (Pphn) Or Hypoxic Respiratory Failure And At Risk For Pphn.

    This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.

Population:
PAH
Start Date:
May 2012
End Date:
May 2021
Phase:
III
Institution:
United Therapeutics
Study Summary
  • This study is an international, multi-center, open-label study designed to provide oral treprostinil (UT-15C) to eligible subjects with pulmonary arterial hypertension who have completed the TDE-PH-310 study. The purpose of this study is to assess the long-term safety of UT-15C and to assess the effects of long-term treatment with UT-15C on exercise capacity.
Population:
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension
Start Date:
October 2016
End Date:
May 2020
Phase:
III
Institution:
Reata Pharmaceuticals, Inc.
Study Summary
  •  

    This study assesses the safety and efficacy of bardoxolone methyl relative to placebo in patients with connective tissue disease-associated pulmonary arterial hypertension to determine the recommended dose range and evaluate the change from baseline in 6-minute walk distance (6MWD) following 24 weeks of study participation.

Population:
CTEPH
Start Date:
December 25, 2018
End Date:
November 2019
Phase:

Institution:
Queen's University
Study Summary
  • Subjects will include 20 clinically stable patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH) recruited from the Pulmonary Hypertension outpatient clinics at Hotel Dieu Hospital, Kingston, Ontario.

    Pulmonary embolism, or clots blocking the blood vessels of the lungs, is a common clinical condition requiring treatment with blood thinners. In most patients, recovery is complete. A small proportion of patients, however, develop complications (high blood pressure in the lung circulation, i.e. pulmonary hypertension). Persisting breathlessness during activity is a common symptom in many of these patients and leads to a reduced ability to engage in daily physical activity. The reason for this activity-related breathlessness remains uncertain and is the main question of the proposed study. Using new sophisticated technology, the investigators will determine the root causes of perceived breathing difficulty. The investigators will test the idea that breathlessness is fundamentally the result of increased drive to breathe from control centers in the brain. The investigators will measure drive to breathe by measuring the electrical activity descending from the brain to the main muscle of breathing - the diaphragm. The investigators will discover if the increased drive to breathe is due to accumulation of carbon dioxide in the blood as a result of poor blood perfusion of areas of the lung due to the effects of blockage by clots. The investigators also will investigate whether weakness and fatigue of the muscles of breathing, as a result of the high breathing demands that are present in patients with blood clots in the lungs, contribute to breathlessness. With this information it is hopeful that better treatment options will be developed to relieve this distressing symptom.

     

Population:
Patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies
Start Date:
April 18, 2017
End Date:
December 2021
Phase:
III
Institution:
Reata Pharmaceuticals, Inc.
Study Summary
  • This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.
     
Population:
Patients coming for cardiac catheterization and healthy controls coming for urology surgery
Start Date:
June 20, 2018
End Date:
December 2019
Phase:

Institution:
The Hospital for Sick Children
Study Summary
  • To investigate if the inflammatory protein, high mobility group box 1 (HMGB1), along with other inflammatory mediators, is elevated in pediatric patients with congenital heart disease (CHD) and pulmonary hypertension as compared to those with CHD alone, or with healthy controls.

     
Population:
PPH
Start Date:
October 2014
End Date:
December 2018
Phase:

Institution:
University of Colorado, Denver
Study Summary
  • Patients are being asked to be in this research study because medical researchers hope that by gathering information about a large number of children with pulmonary hypertension over time, their understanding of the disease process will increase and lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences.
     
Population:
PAH
Start Date:
January 2017
End Date:
January 2020
Phase:
IV
Institution:
Bayer
Study Summary
  • REPLACE is a randomized controlled study to confirm the potential clinical benefit of transition from PDE5i to riociguat. Satisfactory clinical response in patients who are on a stable dose of phosphodiesterase-5inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal will be compared between one group of patients randomized to maintain current treatment and another group where the PDE5i is replaced by riociguat.
Population:
Adults with chronic, stable right HF
Start Date:
April 1, 2018
End Date:
January 2020
Phase:
IV
Institution:
Ottawa Heart Institute Research Corporation
Study Summary
  • The purpose of this study is to evaluate the safety, tolerability and mechanistic effects of spironolactone, an aldosterone receptor antagonist, on sympathetic nervous system activity and right heart function and remodeling in patients with chronic right heart failure.

     
Population:
Pulmonary Arterial Hypertension (PAH) on Top of Conventional Treatments
Start Date:
9/28/2017
End Date:
10/1/2020
Phase:
II
Institution:
Northern Therapeutics
Study Summary
  • The SAPPHIRE clinical trial seeks to establish the efficacy and safety of repeated monthly dosing of autologous EPCs transfected with human eNOS (heNOS) in patients with symptomatic severe PAH on available PAH-targeted medical therapy.
     
Population:
PAH
Start Date:
May 2016
End Date:
December 31, 2019
Phase:
III
Institution:
Actelion
Study Summary
  • The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.
Population:
PPH
Start Date:
August 2015
End Date:
December 2021
Phase:

Institution:
Association for Pediatric Pulmonary Hypertension
Study Summary
  • The TOPP-2 registry is an international, non-interventional, prospective registry including children and adolescents newly diagnosed with pulmonary hypertension (PH) to gain further insights in the disease course and long-term outcome of PH in childhood.

     

Enrolling by Invitation

Population:
PAH
Start Date:
May 8, 2017
End Date:
December 31, 2018
Phase:
II
Institution:
John Granton, University Health Network, Toronto
Study Summary
  • Despite advances in treatment and corresponding improvements in survival, patients with pulmonary arterial hypertension (PAH) remain highly symptomatic. In one survey of 315 patients with PAH, sixty-eight percent had moderate or severe dyspnea on exertion and 40% had a profound and clinically significant deficit in quality of life. Palliative care is being increasingly investigated in life-limiting cardiovascular diseases to alleviate symptoms. In PAH, its implementation is frequently delayed until end-of-life. Opioids are a common palliative care intervention, however the efficacy and safety of opioids for symptom relief in PAH has not been evaluated.
Population:
PPAH
Start Date:
10/1/2012
End Date:
November 2018
Phase:
II
Institution:
University Health Network, Toronto
Study Summary
  • The investigators propose the first prospective, double blind, randomized controlled trial of treatment for pulmonary arterial hypertension (PAH) related to underlying portal hypertension. Specifically the investigators will evaluate the potential efficacy and safety of sildenafil (Revatio) in a 16 week blinded, multicentre study.

Active (not recruiting)

Population:
Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction
Start Date:
April 14, 2010
End Date:
June 6, 2012
Phase:
II
Institution:
Bayer
Study Summary
  • The aim of this study is to assess whether increasing oral doses of Riociguat are safe and improve the well-being, symptoms and outcome in patients with pulmonary hypertension associated with left ventricular systolic dysfunction.
Population:
Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1
Start Date:
July 1, 2009
End Date:
December 31, 2018
Phase:

Institution:
Bayer
Study Summary
  • Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.

     
Population:
PAH
Start Date:
December 2009
End Date:
February 2021
Phase:
III
Institution:
Actelion
Study Summary
  • Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)
Population:
PAH
Start Date:
May 2006
End Date:
December 2020
Phase:
III
Institution:
United Therapeutics
Study Summary
  • This study provides, or continues to provide, UT-15C SR (treprostinil diethanolamine) to eligible patients with pulmonary arterial hypertension who have completed protocols TDE-PH-202, TDE-PH-203, TDE-PH-205, TDE-PH-301, TDE-PH-302, TDE-PH-308 studies or any additional UT-15C SR clinical protocols evaluating subjects with PAH. The study assesses the long term safety of UT-15C and the effect of continued treatment with UT-15C on exercise capacity after one year of treatment.
Population:
Group 3 PH
Start Date:

End Date:

Phase:
IIb
Institution:
Hoffmann-La Roche
Study Summary
  • This Phase IIb, randomized, placebo-controlled, multicenter, international study will evaluate the efficacy, safety, and tolerability of sildenafil or placebo added to pirfenidone (Esbriet) treatment in participants with advanced IPF and risk of Group 3 pulmonary hypertension (PH) who are on a stable dose of pirfenidone with demonstrated tolerability. Participants will be randomized to receive 1 year of treatment with either oral sildenafil or matching placebo while continuing to take pirfenidone.
Population:
PAH
Start Date:
March 2016
End Date:
December 2018
Phase:
III
Institution:
Bellerophon Pulse Technologies
Study Summary
  • An open-label, long-term study to evaluate the safety of inhaled nitric oxide (iNO) in subjects with pulmonary arterial hypertension (PAH) who participated in IK-7001-PAH-201 and to provide these patients with continued access to chronic iNO until the time of approval or when the trial is discontinued due to lack of efficacy.
Population:
CTEPH
Start Date:
February 2015
End Date:
January 2020
Phase:

Institution:
International CTEPH Association
Study Summary
  • The New International CTEPH Database is a prospective, observational multi-center disease registry run by the International CTEPH Association (ICA), which will collect data in chronic thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for approximately 5 years. Its objective is to provide an overview on epidemiology of CTEPH, mode of diagnosis and treatment approaches worldwide as well as determinants of long-term outcomes as measured by New York Heart Association (NYHA) functional class and survival.
Population:

Start Date:
November 2008
End Date:
October 2019
Phase:
III
Institution:
Gilead Sciences
Study Summary
  • Eligible subjects are those participating in countries where ambrisentan is not yet commercially available.

    This Phase 3, international, multicenter, open-label study will monitor the long-term safety of ambrisentan in adults with pulmonary hypertension. The available ambrisentan doses for this study are 5 or 10 mg administered orally once daily; the approved doses of ambrisentan in the United States, Canada, and the European Union are 5 and 10 mg. Investigators will be able to adjust ambrisentan dose as clinically indicated. A minimum of 4 weeks between dose adjustments is required. Participants receiving other therapies for pulmonary hypertension that are not contraindicated for concomitant use with ambrisentan are permitted to enroll in this study and continue to receive such therapies. Participants enrolled in this study will receive treatment with ambrisentan until such time as the investigator or participant chooses to stop ambrisentan treatment, ambrisentan becomes commercially available, or the Sponsor stops the study.